- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01075451
Antimicrobial Drug Use and Resistant Staphylococcus Aureus
May 17, 2013 updated by: Virginia Commonwealth University
Antimicrobial Drug Use and Resistant Staphylococcus Aureus in a Network of Academic Medical Center Hospitals.
The purpose of this investigation is to study the relationships between antimicrobial stewardship program efforts, antimicrobial drug use, and infection control efforts to the incidence rates of hospital acquired infections with Staphylococcus aureus in a sample of US academic medical center hospitals.
Study Overview
Status
Completed
Conditions
Detailed Description
Hospitalized patients can become infected with a variety of microorganisms, but infections caused by Staphylococcus aureus (i.e., "staph" infections) are particularly common.
The main strategy to reduce the number of patients infected with Staph.
aureus is to decrease cross-transmission from one patient to another.
In addition, increasing evidence suggests that improvements in antimicrobial drug use--promoted by hospital Antimicrobial Stewardship programs (ASPs) -- may also favorably impact rates of Staph.
aureus infections.
While many Staphylococcal strains remain susceptible to an old drug called methicillin (methicillin-susceptible Staph aureus, or MSSA), many Staph.
aureus are methicillin-resistant (MRSA).
The drug of choice for MRSA has historically been vancomycin, and vancomycin is now the most commonly prescribed antibiotic in US teaching hospitals.
Vancomycin-resistant Staph.
aureus (VRSA) is still uncommon, but some Staph.
aureus are developing "low level" resistance to vancomycin.
These strains are often called S. aureus with MIC "creep" to vancomycin (SA-MICcreep), and Staphylococcus aureus with Heterogeneous Resistance to Vancomycin (hVISA), but the epidemiology, clinical significance and risk factors for these organisms are not well described.
We will survey UHC participating hospitals to learn more about these organisms, the drug and ASP related risk factors, and whether hospitals are trying to identify these organisms.
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Virginia
-
Richmond, Virginia, United States, 23298
- Virginia Commonwealth University School ofPharamcy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Aggregate antibacterial drug use from adult inpatients at 60 UHC hospitals for 2006 - 2009
Description
Inclusion Criteria:
- NA
Exclusion Criteria:
- NA
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Association between Antimicrobial Stewardship Program and Infection Control efforts, antibacterial drug use and rates of hVISA and other resistant staphylococci.
Time Frame: 2008 and 2009
|
Rates of hVISA and Staph.aureus with MIC creep to vancomycin
|
2008 and 2009
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ron E Polk, Pharm.D., Virginia Commonwealth University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Pakyz AL, MacDougall C, Oinonen M, Polk RE. Trends in antibacterial use in US academic health centers: 2002 to 2006. Arch Intern Med. 2008 Nov 10;168(20):2254-60. doi: 10.1001/archinte.168.20.2254.
- Pakyz AL, Oinonen M, Polk RE. Relationship of carbapenem restriction in 22 university teaching hospitals to carbapenem use and carbapenem-resistant Pseudomonas aeruginosa. Antimicrob Agents Chemother. 2009 May;53(5):1983-6. doi: 10.1128/AAC.01535-08. Epub 2009 Mar 9.
- Pakyz A, Powell JP, Harpe SE, Johnson C, Edmond M, Polk RE. Diversity of antimicrobial use and resistance in 42 hospitals in the United States. Pharmacotherapy. 2008 Jul;28(7):906-12. doi: 10.1592/phco.28.7.906.
- MacDougall C, Polk RE. Variability in rates of use of antibacterials among 130 US hospitals and risk-adjustment models for interhospital comparison. Infect Control Hosp Epidemiol. 2008 Mar;29(3):203-11. doi: 10.1086/528810.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2010
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
February 23, 2010
First Submitted That Met QC Criteria
February 24, 2010
First Posted (Estimate)
February 25, 2010
Study Record Updates
Last Update Posted (Estimate)
May 20, 2013
Last Update Submitted That Met QC Criteria
May 17, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PT104711
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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